Sensored surgical tool and surgical intraoperative tracking and imaging system incorporating same

ABSTRACT

A sensored surgical tool, surgical intraoperative tracking and imaging system incorporating same, and methods, involving a rigid elongate tool body having a substantially rigid tool tip to be displaced and tracked within the surgical cavity so to reproducibly locate the tool tip within the cavity. The tool has one or more tool tip cameras and/or pressure sensors operatively disposed along the body at or proximal to the tool tip.

CROSS REFERENCE TO RELATED APPLICATION(S)

This document is a continuation application, claiming the benefit of,and priority to, the following documents: U.S. patent application Ser.No. 15/896,516, entitled “SENSORED SURGICAL TOOL AND SURGICALINTRAOPERATIVE TRACKING AND IMAGING SYSTEM INCORPORATING SAME,” filed onFeb. 14, 2018, and Canadian Patent Application No. 2,957,977, entitled“SENSORED SURGICAL TOOL AND SURGICAL INTRAOPERATIVE TRACKING AND IMAGINGSYSTEM INCORPORATING SAME,” and filed Feb. 15, 2017, all of which arehereby incorporated by reference herein in their entirety.

FIELD

The present disclosure relates to surgical instruments, tools andsystems, and, in particular, to a sensored surgical tool for use, forexample, within a surgical cavity, such as an open port-based orvisually accessible surgical cavity, and a surgical system incorporatingsuch tool, such as a surgical intraoperative tracking and imagingsystem.

BACKGROUND

In the related art, various surgical site imaging techniques and toolshave been developed to improve the accuracy and ultimate success of agiven surgical procedure. Related art imaging tools for visuallyclosed-access surgical procedures, for example, are those channeledthrough an anatomical lumen, e.g., vascular, intestinal procedures, mayinclude fiber optic scopes, optical coherence tomography (OCT) probes,micro ultrasound transducers, and the like, wherein a generally flexibletool is inserted and channeled to a surgical site of interest.

Visually open-access surgical sites, for example, employing a surgicalaccess port or the like, generally rely on related art external imagingdevices, such as an overhead down-cavity surgical microscope or anexternal videoscope and display system. Accordingly, surgical siteimaging is generally limited to the different fields of view and viewangles available to the external scope and/or surgical microscope, whichnot only generally limits visibility to down-port images but is alsosubject to visibility issues when blood or other fluids immerse thesurgical cavity or port bottom. Given the limited working space withinthe port/cavity, and particularly for neurosurgical applications, thehighly critical nature of any down-port maneuvers and/or tissueinteractions, limited visibility can result in significant surgicalchallenges, particularly, for example, when seeking to blindly locateand address a bleeding site or evaluate externally visually inaccessibleareas within the cavity, such as areas blocked by visually interferingtissue.

Currently, a surgeon will generally seek to reduce the volume ofvisually interfering fluids using a related art suction tool in anattempt to identify and address a bleeding/leaking site, for example,before the cavity/port is re-immersed with fluid. As for gainingvisibility around or below visually interfering tissue, the surgeon mayrather seek to re-angle the external scope or microscope, albeit withinfield of view, and view angle limits prescribed by the externalequipment and surgical cavity/port. Accordingly, significant challengesremain in the related art for adequately visualizing, characterizing,and addressing visually inaccessible, obscured, or obstructed portionsof the surgical cavity.

Therefore, a need exists for technologies addressing the foregoingchallenges experienced in the related art.

SUMMARY

In addressing at least some of the foregoing challenges experienced inthe related art, the subject matter of the present disclosure involves asensored surgical tool, an intraoperative tracking and imaging system,and their methods.

In accordance with an embodiment of the present disclosure, a surgicaltool, operable with an external data processing unit, for use within anopen surgical cavity, comprises: a rigid elongate tool body comprising asubstantially rigid tool tip configured to be displaced and trackedwithin the open surgical cavity for reproducibly locating thesubstantially rigid tool tip within the open surgical cavity, the rigidelongate tool body configured to operate with at least one pressuresensor, at least one camera, and the external data processing unit; anda suction tool comprising a suction tool tip portion, the suction toolconfigured to operate with at least one other pressure sensor, at leastone other camera, and the external data processing unit, whereinimaging, locating, and mapping inner cavity characteristics areconsidered by the external data processing unit in real-time during asurgical procedure, the external data processing unit operable to:associate at least one pressure reading, corresponding to at least onesensor signal from the at least one pressure sensor, with at least onelocation of each at least one pressure sensor within the open surgicalcavity; associate at least one pressure reading, corresponding to atleast one sensor signal from the at least one other pressure sensor,with at least one location of each at least one other pressure sensorwithin the open surgical cavity; and associate at least one respectiveinner-cavity image with at least one location of the substantially rigidtool tip and at least one location of the suction tool tip portion.

In accordance with an embodiment of the present disclosure, a method ofproviding a surgical tool, operable with an external data processingunit, for use within an open surgical cavity, comprises: providing arigid elongate tool body comprising a substantially rigid tool tipconfigured to be displaced and tracked within the open surgical cavityfor reproducibly locating the substantially rigid tool tip within theopen surgical cavity, the rigid elongate tool body configured to operatewith at least one pressure sensor, at least one camera, and the externaldata processing unit; and providing a suction tool comprising a suctiontool tip portion, the suction tool configured to operate with at leastone other pressure sensor, at least one other camera, and the externaldata processing unit, wherein imaging, locating, and mapping innercavity characteristics are considered by the external data processingunit in real-time during a surgical procedure, the external dataprocessing unit operable to: associate at least one pressure reading,corresponding to at least one sensor signal from the at least onepressure sensor, with at least one location of each at least onepressure sensor within the open surgical cavity; associate at least onepressure reading, corresponding to at least one sensor signal from theat least one other pressure sensor, with at least one location of eachat least one other pressure sensor within the open surgical cavity; andassociate at least one respective inner-cavity image with at least onelocation of the substantially rigid tool tip and at least one locationof the suction tool tip portion.

In accordance with an embodiment of the present disclosure, a method ofimaging, locating, and mapping inner cavity characteristics within anopen surgical cavity by way of a surgical tool, operable with anexternal data processing unit, comprises: providing the surgical tool,providing the surgical tool comprising: providing a rigid elongate toolbody comprising a substantially rigid tool tip configured to bedisplaced and tracked within the open surgical cavity for reproduciblylocating the substantially rigid tool tip within the open surgicalcavity, the rigid elongate tool body configured to operate with at leastone pressure sensor, at least one camera, and the external dataprocessing unit; and providing a suction tool comprising a suction tooltip portion, the suction tool configured to operate with at least oneother pressure sensor, at least one other camera, and the external dataprocessing unit; and considering imaging, locating, and mapping innercavity characteristics in real-time during a surgical procedure by theexternal data processing unit, considering comprising: associating atleast one pressure reading, corresponding to at least one sensor signalfrom the at least one pressure sensor, with at least one location ofeach at least one pressure sensor within the open surgical cavity;associating at least one pressure reading, corresponding to at least onesensor signal from the at least one other pressure sensor, with at leastone location of each at least one other pressure sensor within the opensurgical cavity; and associating at least one respective inner-cavityimage with at least one location of the substantially rigid tool tip andat least one location of the suction tool tip portion.

Other aspects, features and/or advantages will become more apparent uponreading the following non-restrictive description of specificembodiments thereof, given by way of example only with reference to theaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWING(S)

Several embodiments of the present disclosure are provided, by way ofexamples only, with reference to the appended drawings, wherein:

FIG. 1 is a diagram illustrating a perspective view of a navigationsystem, such as a medical navigation system, comprising a patientreference device, in an environmental context, such as an operationroom;

FIG. 2 is a schematic diagram illustrating a navigation system, such asa medical navigation system, comprising a patient reference device;

FIG. 3 is a schematic diagram illustrating a sensored surgical tool andassociated control and processing unit;

FIG. 4A is a schematic diagram illustrating a cross-sectional view of adisposable tool tip portion of the sensored surgical tool, as shown inFIG. 3;

FIG. 4B is a schematic illustrating a top plan view of the disposabletool tip portion, as shown in FIG. 4A;

FIG. 5 is a diagram illustrating an access port-based surgical procedurebeing conducted by way of a navigation system;

FIG. 6A is a diagram illustrating a perspective view of a trackablepointing tool having distinctly configured tracking markers;

FIG. 6B is a diagram illustrating a perspective view of a trackablepointing tool having distinctly configured tracking markers;

FIG. 6C is a diagram illustrating a perspective view of a trackablepointing tool having distinctly configured tracking markers;

FIG. 6D is a diagram illustrating a perspective view of a trackablepointing tool having distinctly configured tracking markers;

FIG. 6E is a diagram illustrating a perspective view of a trackablesurgical access port having a set of tracking markers;

FIG. 6F is a diagram illustrating a front elevation view of a trackablesurgical access port having a set of tracking markers;

FIG. 6G is a diagram illustrating a side view of a trackable surgicalaccess port having a set of tracking markers;

FIG. 6H is a diagram illustrating a top plan view of a trackablesurgical access port having a set of tracking markers;

FIG. 7 is a diagram illustrating a perspective view of the pointingtool, as shown in FIG. 6C, engaged with a trackable access port;

FIG. 8 is a schematic diagram illustrating a relationship amongcomponents of an overall surgical navigation system;

FIG. 9 is a schematic diagram illustrating a preoperative surgicalplanning system for use with a medical navigation system;

FIG. 10 is a schematic diagram illustrating an intraoperative surgicalmanagement system for use with a medical navigation system;

FIG. 11 is a flow diagram illustrating a method of providing a surgicaltool, operable with an external data processing unit, for use within anopen surgical cavity; and

FIG. 12 is a flow diagram illustrating a method of imaging, locating,and mapping inner cavity characteristics within an open surgical cavityby way of a surgical tool operable with an external data processingunit.

Elements in the several figures are illustrated for simplicity andclarity and have not necessarily been drawn to scale. For example, thedimensions of some of the elements in the figures may be emphasizedrelative to other elements for facilitating understanding of the variouspresently disclosed embodiments. Also, common, but well-understoodelements that are useful or necessary in commercially feasibleembodiment are often not depicted in order to facilitate a lessobstructed view of these various embodiments of the present disclosure.

DETAILED DESCRIPTION

The embodiments described herein provide different examples of asensored to surgical tool, and system incorporating same. The tools,systems and methods described herein may be useful in the fieldneurosurgery, including oncological care, neurodegenerative disease,stroke, brain trauma, and orthopedic surgery. However, the subjectmatter of the present disclosure may extend or apply to other conditionsor fields of medicine, and such extensions or applications areencompassed by the present disclosure. For example, the tools, systemsand methods described herein encompass surgical processes that areapplicable to surgical procedures for brain, spine, knee, and any otherregion of the body that will benefit from the use of an access port orsmall open orifice to define and access a surgical cavity within theinterior of an animal body, such as a human body.

Various tools, systems, apparatuses, devices, or processes arebelow-described and provide examples of sensored surgical tools, andsystems incorporating same, in accordance with embodiments of thepresent disclosure. None of the below-described embodiments limits anyclaimed embodiment; and any claimed embodiment may also encompass tools,systems, apparatuses, devices, or processes that may differ from thebelow-described examples. The embodiments of the present disclosure arenot limited to tools, systems, apparatuses, devices, or processes havingall of the features of any one of the below-described tools, systems,apparatuses, devices, or processes or to features common to some or allof the below-described tools, systems, apparatus, devices, or processes.

Furthermore, this Detailed Description sets forth numerous specificdetails in order to provide a thorough understanding of the variousembodiments described throughout the present disclosure. However,embodiments described herein may be practiced without these specificdetails. In other instances, well-known methods, procedures andcomponents have not been described in detail so as not to obscure theembodiments described herein.

For instance, in accordance with some aspects of the present disclosure,a sensored surgical tool is described for use in a surgical cavity toprovide increased intraoperative inner-cavity visibility andcharacterization to supplement external imaging device capabilities, forexample, to access, image and/or characterize obscured, obstructed orotherwise externally visually inaccessible regions of the surgicalcavity. In some aspects, such enhanced inner-cavity characterization mayimprove intraoperative imaging of the cavity while also assisting inlocating and addressing inner-cavity bleeding or other fluid immersions,for example, by location-tracking and mapping imaging andcharacterization capabilities of the herein-described tools and systems.

In accordance with one aspect, there is provided a surgical tool for usewithin a surgical cavity, the surgical tool comprising: a rigid elongatetool body having a substantially rigid tool tip to be displaced andtracked within the surgical cavity so to reproducibly locate said tooltip within the cavity; and a pressure sensor operatively disposed alongsaid body at or proximal to said tool tip and responsive to pressurevariations applied thereto from within the surgical cavity to output asensor signal representative thereof as the tool is displaced within thecavity, wherein said sensor signal is externally communicable toassociate respective inner-cavity pressure readings with tracked tooltip locations.

In accordance with some embodiments of the present disclosureembodiment, at least one of: the pressure sensor is laterally orientedrelative to said tip, the surgical tool further comprises two or moresaid pressure sensor at or proximate said tool tip, the surgical toolfurther comprises a set of fiducial markers externally coupled in afixed configuration to an externally extending portion of said elongatebody, wherein said markers are trackable by an external tracking systemto automatically determine said tracked tool tip locations withreference to the cavity based on a respective tracked position of saidmarkers, the surgical tool further comprises a radio frequencytransmitter to wirelessly communicate said sensor signal, the pressuresensor comprises two or more pressure sensors collocated at or towardsaid tool tip, the surgical tool further comprises a suction tool at orproximal to said tip to concurrently provide suction within the surgicalcavity around said tip, and the surgical cavity is externally visible toan external camera aligned therewith, and wherein said tip is operableas a trackable pointer within the cavity.

In accordance with some embodiments of the present disclosureembodiment, at least one of: the surgical tool further comprises atleast one camera disposed and laterally-oriented along said body at orproximal to said tip so to capture lateral images from within thesurgical cavity, wherein said lateral images are externally communicableto associate respective inner-cavity images with tracked tool tiplocations, and the surgical tool further comprises at least onecomplementary camera disposed along said body at or proximal to said tipso to capture complementary images of the surgical cavity along acomplementary imaging axis angled downwardly relative to saidlaterally-oriented camera so to construct a 3D inner-cavity mapping oran enlarged field of view image of the surgical cavity from said lateralimages and said complementary images.

In accordance with some embodiments of the present disclosureembodiment, at least one of: the surgical cavity is visibly accessibleto an external camera or scope aligned therewith, and wherein saidinner-cavity images are complementary to external images captured bysaid external camera or scope in enhancing inner-cavity visualization,the tip is movable within the cavity to track pressure variationsresulting from inner-cavity bleeding in locating a bleeding site withinthe cavity, and the tool body comprises a reusable tool shaft portionand a disposable tool tip portion removably operatively connectable tosaid shaft portion, wherein said tip portion comprises said tip and saidpressure sensor.

In accordance with another aspect, there is provided a surgical systemfor performing surgery through an externally accessible surgical cavity,the system comprising: a surgical tool comprising: a rigid elongate toolbody having a substantially rigid tool tip to be displaced and trackedwithin the surgical cavity so to reproducibly locate said tool tipwithin the cavity; and a pressure sensor operatively disposed along saidbody at or proximal to said tool tip and responsive to pressurevariations applied thereto from within the surgical cavity to output asensor signal representative thereof as the tool is displaced within thecavity; an external tracking system operatively interfacing with saidsurgical tool to automatically track a location of said tool tip withinthe cavity; and an external data processing unit operable to associate agiven pressure reading associated with said sensor signal with acorresponding location of said pressure sensor within the cavity.

In accordance with some embodiments of the present disclosureembodiment, at least one of: the system further comprises a set offiducial markers externally coupled in a fixed configuration to anexternally extending portion of said elongate body, and wherein saidmarkers are trackable by an external surgical navigation system toautomatically associate said corresponding location of said pressuresensor within the cavity based on a respectively tracked position ofsaid markers, and the pressure sensor is laterally oriented relative tosaid tip.

In accordance with another aspect, there is provided a surgical tool foruse within a surgical cavity, the surgical tool comprising: a rigidelongate tool body having a substantially rigid tool tip to be displacedand tracked within the surgical cavity so to reproducibly locate saidtool tip within the cavity; and at least one laterally-oriented cameraoperatively disposed along said body at or proximal to said tip so tocapture lateral inner-cavity images of the surgical cavity for output asthe tool is displaced within the cavity, wherein said lateralinner-cavity images are externally communicable to associate respectivelateral inner-cavity images with tracked tool tip locations.

In accordance with some embodiments of the present disclosureembodiment, at least one of: the surgical tool further comprises a setof fiducial markers externally coupled in a fixed configuration to anexternally extending portion of said elongate body, wherein said markersare trackable by an external tracking system to automatically determinesaid tracked tool tip locations with reference to the cavity based on arespective tracked position of said markers, the surgical tool furthercomprises a radio frequency transmitter to wirelessly communicate saidlateral inner-cavity images, and the surgical tool further comprises asuction tool at or proximal to said tip to concurrently provide suctionwithin the surgical cavity around said tip.

In accordance with some embodiments of the present disclosureembodiment, at least one of: the surgical tool further comprises atleast one complementary camera disposed along said body at or proximalto said tip so to capture complementary images of the surgical cavityalong a complementary imaging axis angled downwardly relative to saidlaterally-oriented camera so to construct a 3D inner-cavity mapping oran enlarged field of view image of the surgical cavity from said lateralimages and said complementary images, the surgical cavity is visiblyaccessible to an external camera or scope aligned therewith, and saidinner-cavity images are complementary to external images captured bysaid external camera or scope in enhancing inner-cavity visualization,and the tool body comprises a reusable tool shaft portion and adisposable tool tip portion removably operatively connectable to saidshaft portion, wherein said tip portion comprises said tip and saidcamera.

In accordance with another aspect, there is provided a surgical systemfor performing surgical procedures via a surgical cavity, the systemcomprising: a surgical tool comprising: a rigid elongate tool bodyhaving a substantially rigid tool tip to be displaced and tracked withinthe surgical cavity so to reproducibly locate said tool tip within thecavity; and at least one laterally-oriented camera operatively disposedalong said body at or proximal to said tip so to capture lateralinner-cavity images of the surgical cavity for output as the tool isdisplaced within the cavity, wherein said lateral inner-cavity imagesare externally communicable to associate respective lateral inner-cavityimages with tracked tool tip locations; an external tracking systemoperatively interfacing with said surgical tool to automatically track alocation of said tool tip within the cavity; and an external imageprocessing unit operable to associate a given lateral inner-cavity imagecaptured via said camera with a corresponding location of said camerawithin the cavity.

In accordance with some embodiments of the present disclosureembodiment, at least one of: the system further comprises an externalimaging device axially aligned with the surgical cavity to capturedownward images thereof; wherein said image processing unit is furtheroperable to concurrently render downward images and lateral images ofthe surgical cavity as the surgical tool is moved, the camera has afootprint no greater than about 2 mm×2 mm, or no greater than about 1mm×1 mm, the camera operates in a spectral region selected from visibleand a near infrared, the surgical cavity is at least partially definedby a surgical port.

In one embodiment, the system further comprises a set of fiducialmarkers externally coupled in a fixed configuration to an externallyextending portion of said elongate body; wherein said markers aretrackable by said external tracking system to automatically determinesaid tracked tool tip locations with reference to the cavity based on arespective tracked position of said markers.

In one embodiment, the image processing unit is further operable to mapan internal region of the surgical cavity by digitally assembling a setof said lateral images corresponding to said region and mapped theretovia each said corresponding location.

In one embodiment, the tool further comprises at least one complementarycamera disposed along said body at or proximal to said tip so to capturecomplementary images of the surgical cavity along a complementaryimaging axis angled downwardly relative to said laterally-orientedcamera so to construct a 3D inner-cavity mapping or an enlarged field ofview image of the surgical cavity from said lateral images and saidcomplementary images.

Referring to FIGS. 1 and 2, together, this diagram illustrates aport-based surgical system incorporating a sensored surgical tool, andin accordance with embodiments of the present disclosure. The sensoredsurgical tool is described herein within the context of a port-basedsurgical system and associated tracking/navigation system, may also beamenable to other similar or alternate surgical systems and procedures,and that, without departing from the general scope and nature of thepresent disclosure. The utility and applicability of theherein-described sensored surgical tool is not limited to port-basedand/or neurological procedures, but rather, may prove particularlyuseful and desirable in a number of surgical environments in which oneor more tracked surgical tools are to be operated within a givensurgical cavity where inner-cavity imaging and/or characterization isotherwise obscured or hidden from the surgeon or other medicalpractitioner.

Still referring to FIGS. 1 and 2, together, in the illustrated examples,the surgical system encompasses an exemplary surgical navigation system200 operable to track various patient reference devices, in anenvironmental context, such as an operation room (OR). The system 200supports, facilitates, and enhances minimally invasive access port-basedsurgery using a minimally invasive access port-based surgical procedure,though non port-based procedures may equally be considered herein asnoted above.

Still referring to FIGS. 1 and 2, together, by example only, a surgeon101 conducts a minimally invasive access port-based surgery on asubject, such as a patient 102, in an OR environment. The navigationsystem 200 generally includes an equipment tower 201, a robotic arm 202to support an external optical scope 204, and at least one display ormonitor 205, 211 for respectively displaying video images 205 a, 211 a.By example only, an operator 103 is also present to operate, control,and provide assistance for the system 200.

Referring to FIG. 2, the equipment tower 201 is generally mountable on aframe, e.g., a rack or a cart, and is configured to accommodate a powersupply, e.g., an AC adapter power supply, and at least one computer orcontroller operable by at least one a set of instructions, storable inrelation to at least one non-transitory memory device, corresponding toat least one of surgical planning software, navigation/trackingsoftware, or robotic software for managing at least one of the roboticarm 202 and at least one instrument, such as a surgical instrument,e.g., the access port 206, the introducer 210, and/or one or more otherdownstream (instrumented) surgical tools (not shown) used during theprocedure. For example, the computer comprises at least one of a controlunit and a processing unit, such as control and processing unit 400 or1530, as respectively shown in FIGS. 8 and 3.

Still referring to FIG. 2, in the illustrated embodiment, the equipmenttower 201 comprises a single tower configured to facilitate coupling ofthe at least one display device, e.g., a primary display device 211 anda secondary display device 205, with the at least one piece ofequipment. However, other configurations are also encompassed by thepresent disclosure, such as the equipment tower 201 comprising dualtowers configured to facilitate coupling of a single display, etc. Theequipment tower 201 is also configurable to accommodate anuninterruptible power supply (UPS) for providing emergency power.

Still referring to FIG. 2, to maintain constant positioning of thepatient's anatomy of interest during a given procedure, the patient'sanatomy may be held in place by a holder appropriate for the procedurein question. For example, in a port-based neurosurgical procedure, apatient's head can be retained by a head holder 217. A craniotomy isperformed; and a dura flap is formed and retracted. The access port 206and the introducer 210 can then be inserted into the patient's brain 102b; and the planned procedure is executed while the patient's headremains effectively immobile.

Still referring to FIG. 2 and referring back to FIG. 1, the system alsoincludes a tracking system 213 that is generally configured to track atleast one instrument, such as a surgical instrument or tool. Thetracking system is initially utilized to track the access port 206 andthe introducer 210 while the access port is being introduced within thepatient's brain so to ultimately locate and define the surgical site andsurrounding surgical cavity. However, other sensored or non-sensoredintraoperative surgical tools, such as, but not limited to, inner-cavitypointing tools, suction tools, tissue probes, e.g., Raman, OCT probes,etc., resection tools and the like, are also advantageously tracked bythe tracking system to enhance accuracy and precision of executedoperative procedures. Instrument tracking can thus significantly assistthe surgeon 101 during the minimally invasive access port-based surgicalprocedure (or like procedures) both in guiding and confirming proceduralactions, but also in aligning real-time surgical cavity imaging andcharacterization, as detailed below within the context of tip-sensoredsurgical tools, with preoperative imaging data and intraoperativeexternal imaging, e.g., captured via external optical scope 204 and/orother cameras discussed below. Accordingly, tracking sensored tools suchas pointing and/or suction tools can significantly benefit enhanced orcomplementary inner-cavity imaging, localization, characterizationand/or mapping.

Still referring to FIG. 2, accordingly, the tracking system 213 isconfigured to track and determine, e.g., in real-time by way of a set ofinstructions corresponding to tracking software and storable in relationto at least one non-transitory memory device, the location of the one ormore tracked instruments during the surgical procedure, while alsogenerally tracking a position of the robotic arm 202. The trackingsystem 213 generally comprises at least one sensor (not shown) fordetecting at least one fiducial marker 212 disposable in relation theone or more OR items, e.g., surgical arm 202, and/or surgicalinstruments (introducer 210) to be tracked. In one example, the trackingsystem 213 comprises a three-dimensional (3D) optical tracking stereocamera, such as a Northern Digital Imaging® (NDI) optical trackingstereo camera, which can be configured to locate reflective spheretracking markers 212 in 3D space.

Still referring to FIG. 2, in another example, the tracking camera 213comprises a magnetic camera, such as a field transmitter, where receivercoils are used to locate objects in 3D space. Accordingly, location dataof the mechanical arm 202, the access port 206, the introducer 210, andits associated pointing tool, and/or other tracked instruments/tools,may be determined by the tracking camera 213 by automated detection oftracking markers 212 placed on these tools, wherein the 3D position andthe orientation of these tools is effectively inferred and tracked bytracking software from the respective position of the tracked markers212.

Still referring to FIG. 2, the secondary display 205 provides an outputof the tracking camera 213, which may include, but is not limited to,axial, sagittal and/or coronal views as part of a multi-view display,for example, and/or other views as may be appropriate, such as viewsoriented relative to the at least one tracked instrument, e.g.,perpendicular to a tool tip, in-plane of a tool shaft, etc. These andother views may be considered in various single or multi-viewcombinations, without departing from the general scope and nature of thepresent disclosure.

Still referring to FIG. 2, minimally invasive brain surgery using accessports is a recent method of performing surgery on brain tumors. In orderto introduce an access port 206 into a brain, such as the patient'sbrain 102 b, of a patient's head 102 a, an introducer, e.g., theintroducer 210, comprises an atraumatic tip disposable within the accessport 206 to facilitate positioning the access port 206 within thepatient brain 102 b. The introducer 210 further comprises at least onefiducial marker 212 for facilitating tracking by the tracking system213. Generally, tracked tools, such as introducer 210, include aplurality of fiducial markers to enhance trackability in 3D space.

Still referring to FIG. 2, after the introducer 210 and the access port206 are inserted into the brain 102 b, the introducer 210 is removed tofacilitate access to the tissue of the brain 102 b through the centralopening of the access port 206. However, after the introducer 210 isremoved, the access port 206 is no longer being tracked by the trackingsystem 213. However, the access port 206 is indirectly trackable by wayof additional pointing tools (not shown) configured for identificationby the navigation system 200.

Still referring to FIG. 2, the navigation system 200 further comprises aguide clamp 218 for retaining the access port 206. The guide clamp 218is configured to optionally engage and disengage the access port 206,eliminating the need to remove the access port 206 from the patient 102.In some embodiments, the access port 206 is configured to slide up anddown within the guide clamp 218 in a closed position. The guide clamp218 further comprises a locking mechanism (not shown), the lockingmechanism being attachable or integrable in relation to the guide clamp218, and the locking mechanism being optionally manually actuatable,e.g., using one hand as further below described.

Still referring to FIG. 2, the navigation system 200 further comprisesan articulating arm 219, such as a small articulating arm, configured tocouple with the guide clamp 218. The articulating arm 219 comprises upto six (6) degrees of freedom for facilitating positioning of the guideclamp 218. The articulating arm 219 is attachable at a location inrelation to the head holder 217, or in relation to any other suitablepatient support structure, to ensure, when locked in place, that theguide clamp 218 is fixed in relation to the patient's head 102 a. Thearticulating arm 219 comprises an interface 219 a disposable in relationto the guide clamp 218, wherein the interface 219 a is at least one offlexible or lockable into place. Flexibility of the interface 219 afacilitates movability of the access port 206 into various positionswithin the brain 102 b, yet still maintains rotatability about a fixedpoint.

Still referring to FIG. 2, the navigation system 200 further, oralternatively, comprises a plurality of wide-field cameras, e.g., twoadditional wide-field cameras (not shown) being implemented with videooverlay information, wherein one camera is mountable in relation to theoptical scope 204 and the other camera is mountable in relation to thenavigation system 213, e.g., within the context of an electromagnetictracking system. In the case of the navigation system 213 comprising anoptical tracking device, a video image can be directly extractedtherefrom. Video overlay information can then be used to enhanceavailable intraoperative information, for example, by providing an imagedisplaying a physical space and confirming tracking system registrationalignment and optional corresponding text and/or indicia, an imagedisplaying a motion range of the robotic arm 202 holding the opticalscope 204 and optional corresponding text and/or indicia, and/or animage displaying a guide head positioning and a patient positioning andoptional corresponding text and/or indicia.

Referring to FIGS. 3, 4A, and 4B, together, FIG. 3 is a schematicdiagram illustrates a sensored surgical tool and associated control andprocessing unit, in accordance with an embodiment of the presentdisclosure, FIG. 4A is a schematic cross-sectional view of a disposabletool tip portion of the sensored surgical tool, as shown in FIG. 3, inaccordance with an embodiment of the present disclosure, and FIG. 4B isa schematic top plan view of the disposable tool tip portion, as shownin FIG. 4A, in accordance with an embodiment of the present disclosure.Other image overlays, as below described in greater detail, furthercomprise intraoperative cavity imaging and/or characterization data,e.g., colour mapping, partial image transparency overlay, text and/orindicia, such as provided by a sensored tool, for example including, butnot limited to, real-time inner cavity images, e.g., visible, nearinfrared (IR), etc., provided by tool tip mounted camera(s), real-timeinner cavity pressure readings (e.g., localized fluid pressure readings,pressure gradients, pressure mappings, etc.) provided by tool tipmounted pressure sensor(s) and/or sensor arrays, and other such readingsof interest given the application at hand. Using such real-timeintraoperative inner cavity imaging and characterization data may notonly enhance other intraoperative images, such as those rendered byoverhead scopes and/or cameras, but also seamlessly integrate withpreoperative images and/or data, for instance, acquired pre-operativelyusing one more imaging techniques. Accordingly, the surgeon and/or othersurgical equipment operator can execute procedures and/or actions withgreater clarity, certainty and visibility, thus leading to improvedoutcomes and risk reduction.

Referring to FIG. 5, this diagram illustrates an access port-basedsurgical procedure conducted by way of the navigation system 200, inaccordance with an embodiment of the present disclosure. In thisexample, a surgeon 501 is resecting a tumor from the brain of a patient502 through an access port 504. An external scope 505 is coupled with arobotic arm 504, and is used to view down port 504 at a sufficientmagnification to allow for enhanced visibility down port 504. The outputof external scope 505 is rendered on a visual display.

Referring to FIG. 5, the procedure involves disposing active or passivefiduciary markers, respectively, 507, 508, e.g., spherical markers, inrelation to at least one of the access port 504 or the external scope505 for facilitating their tracking (location of these tools) by thetracking system, e.g., tracking system 213, as shown in FIG. 2. Theactive or passive fiduciary markers 507, 508 are sensed by sensors ofthe tracking system 213, whereby identifiable points are provided. Atracked instrument is typically indicated by sensing a grouping ofactive or passive fiduciary markers 507, 508, whereby a rigid body, suchas a tool, is identified by the tracking system 213, and whereby theposition and orientation in 3D of a tracked instrument, such as a tool,is determinable. A substantially rigid tool is tracked in 3D space toeffectively locate and orient the tool and its various segments andconstituent components, provided such segments/components are previouslydefined and stored against the tracked tool type. Accordingly, a trackedtool invokes not only general tracking, but also tracking, for example,of the tool's tip or body, and any sensors, as will be detailed below,that may be operatively coupled thereto in a designated configuration,e.g., at or near a tool tip, angled relative to a tool tip or shaft,displaced and/or angled relative to other tool-mounted sensors, etc.Typically, a minimum of three active or passive fiduciary markers 507,508 are placed on a tracked tool to define the instrument. In theseveral figures included herewith, four active or passive fiduciarymarkers 507, 508 are used to track each tool, by example only.

Still referring to FIG. 5, in one particular example, the fiduciarymarkers comprise reflective sphere markers in combination with anoptical tracking system to determine spatial positioning of the surgicalinstruments within the operating field. The spatial position ofautomated mechanical arm(s) or robotic arm(s) used during surgery mayalso be tracked in a similar manner. Differentiation of the types oftools and targets and their corresponding virtual geometrically accuratevolumes can be determined by the specific orientation of the reflectivespheres relative to one another giving each virtual object an individualidentity within the navigation system. The individual identifiers canrelay information to the system as to the size and virtual shape of thetool within the system. The identifier can also provide information suchas the tool's central point, the tools' central axis, the tool's tip,etc. The virtual tool may also be determinable from a database of toolsprovided to the navigation system 200. The marker positions can betracked relative to an object in the operating room such as the patient.Other types of markers that can be used may include, but are not limitedto, radio frequency (RF), electromagnetic (EM), pulsed and un-pulsedlight-emitting diodes (LED), glass spheres, reflective stickers, uniquestructures and patterns, wherein the RF and EM would have specificsignatures for the specific tools to which they would be attached. Thereflective stickers, structures, and patterns, glass spheres, LEDs couldall be detected using optical detectors, while RF and EM could bedetected using antennas. Advantages to using EM and RF tags may includeremoval of the line of sight condition during the operation, where usingthe optical system removes the additional noise from electrical emissionand detection systems.

Still referring to FIG. 5, in a further embodiment, printed or3D-configuration markers are used for detection by an auxiliary cameraand/or external scope. The printed markers are also used as acalibration pattern to provide distance information (3D) to the opticaldetector. These identification markers comprise distinct configurations,such as concentric circles with different ring spacing, and/or differenttypes of bar codes. Furthermore, in addition to using markers, thecontours of known objects, e.g., side of the port, top ring of the port,shaft of pointer tool, etc., can be made recognizable by the opticalimaging devices through the tracking system 213. Similarly, or inaddition thereto, structural information relating to each tool (size,dimensions, distance and geometric orientation relative to markers) isused to extrapolate the position and orientation various tool segments,such as the tool tip, and various sensors that are operatively mountedthereon or associated therewith.

Still referring to FIG. 5, while a number of tracking techniques andrelated marker types are herein listed, other techniques, includingfuture techniques, are considered within the present disclosure tosupport and enhance operation of the tracked surgical tools, e.g.,sensored tools, as herein described. The tracking technique for eachinstrument generally enables tracking of the instrument's position andorientation within a given frame of reference, in which the position andthe orientation can be tracked, relayed, and/or rendered on the surgicalsystem's one or more displays to visually locate the tool, ordata/images acquired thereby, within the context of the procedure takingplace and/or any otherwise available preoperative and/or intraoperativeimages/details.

Referring to FIG. 6A, this diagram illustrates, in a perspective view, atrackable tool, such as a tracked pointing tool 601, having distinctlyconfigured tracking markers, such as a set of tracking markers 610, inaccordance with an embodiment of the present disclosure. The tool 601comprises a rigid pointer or pointing tool 600 rigidly coupled with aset of tracking markers 610 fixedly disposed relative thereto in adesignated configuration geometry that is recognizable by the trackingsystem, e.g., tracking system 213, as shown in FIG. 2, in accordancewith an embodiment of the present disclosure. In this example, themarkers 610 are fixedly coupled with the tracked pointing tool 600 viarespective connector beams 615 attached to respective laterallyextending arms 620 forming a box-like configuration in a plane of thetool's handle 625.

Referring to FIG. 6B, this diagram illustrates, in a perspective view, atrackable tool, such as a tracked surgical tool 602, having distinctlyconfigured tracking markers, such as a set of tracking markers 610, inaccordance with an embodiment of the present disclosure. The surgicaltool 602, again is defined by a pointer or pointing tool 640 and relatedtracking markers, such as a set of 610; however, in this embodiment, thetracked surgical tool 602 is rigidly coupled with the pointing tool 640via a laterally splayed support arm structure 642.

Referring to FIG. 6C, this diagram illustrates, in a perspective view, atrackable tool, such as a tracked surgical tool 603, having distinctlyconfigured tracking markers, such as a set of tracking markers 610, inaccordance with an embodiment of the present disclosure. The trackedsurgical tool 603 is defined by a pointer or pointing tool 650 andrelated tracking markers, such as the set of markers 610, and is rigidlycoupled with the pointing tool 650 via an intersecting support armstructure 652.

Referring to FIG. 6D, this diagram illustrates, in a perspective view, atrackable pointing tool, such as a tracked surgical tool 604, havingdistinctly configured tracking markers, such as a set of trackingmarkers 610, in accordance with an embodiment of the present disclosure.The tracked surgical tool 604 is defined by a pointer or pointing tool660 and related tracking markers, such as the set of markers 610, and istime rigidly coupled with the pointing tool 660 via a T-shaped supportarm structure 662.

Referring back to FIGS. 6A-6D, in each of the examples shown therein,the tracked tool comprises a pointing tool, although other surgicalinstruments may also be used and encompassed by the present disclosureto provide a like effect. For instance, a suction or resection tool, orother surgical probe, may also be considered in which tracking iseffectively provided by appropriate markers and a tracking system, andwhereby a position and orientation of the tracked tool may be adequatelytracked, relayed and rendered during the procedure. As detailed furtherbelow, the further instrumentation of the surgical tool, e.g., sensoredtool tip, either a pointing or other tool, to acquire inner-cavity dataand/or images, as considered herein, may also apply to enhance real-timeintraoperative data/imaging resources.

Referring to FIGS. 6E-6H, together, FIG. 6E is a diagram illustrating aperspective view of a trackable surgical access port having a set oftracking markers, FIG. 6F is a diagram illustrating a front elevationview of a trackable surgical access port having a set of trackingmarkers, FIG. 6G is a diagram illustrating a side view of a trackablesurgical access port having a set of tracking markers, and FIG. 6H is adiagram illustrating a top plan view of a trackable surgical access porthaving a set of tracking markers, in accordance with embodiments of thepresent disclosure.

Still referring to FIGS. 6E-6H, together, for completeness, othersurgical devices may also be intraoperatively tracked, as noted above.For example, these figures respectively provide perspective, frontelevation, side and top plan views of a surgical port 680 rigidlyassociated with a corresponding set of markers 610 coupled therewith viaa support structure 682. The arrangement enables clear visibility of thefiducial or tracking markers 610 to the tracking system 213, whileensuring that the markers 610 do not interfere with surgical tools thatare inserted through the access port 680. The non-uniform structure ofthe extended arm 682 for the markers 610 enables the tracking system 213to discern both the position and the orientation of the access port 680in response to instructions corresponding to the tracking software, forexample.

Referring to FIG. 7, this diagram illustrates, in a perspective view,the pointing tool 603, as shown in FIG. 6C, engaged with a trackableaccess port 690, whereby the tracking markers 610 rigidly associatedwith the pointing tool 650 via support structure 652 are automaticallydiscernible by the tracking/navigation system from the tracking markers692 rigidly associated with the access port 690 via distinct supportstructure 694, in accordance with an embodiment of the presentdisclosure. Accordingly, the pointing tool 650 and access port 690 areseparately trackable by the tracking system 213 of the navigation system200 and are differentiable as unique objects in images rendered on thedisplay device 205.

Still referring to FIG. 7, as noted above, by mapping each instrument'sposition and orientation, the tracking system, e.g., system 213, asshown in FIG. 2, also generally extrapolates a location and orientationof the instrument's various segments, such as an instrument's tip, forexample, when located and used within the surgical cavity, e.g.,down-port location and orientation in the context of a port basedprocedure. Accordingly, by instrumenting the tip or other segment of atrackable tool, instrumentation-related (sensor) data may also bedynamically associated with the tracked position and orientation of thetool, e.g., the tool tip, and effectively mapped in relation theretoeven when the tool tip location is obscured to the externalviewer/scope. Therefore, a tracked sensored tool, e.g., the tool tip,provides real-time intraoperative visibility otherwise unavailable byusing preoperative imaging and intraoperative external scope or cameraview angles. Using video and image overlays, as herein described,tracked tool tip instrumentation may further accentuate availableintraoperative data by enhancing real-time data available during theprocedure, which is otherwise unavailable using an external scope andcameras.

Still referring to FIG. 7, for example, a tracked sensored tool tip maybe enhanced via the disposition of one or more cameras, e.g., miniaturecamera with a micro lens, at the tool tip to provide real-timeintraoperative inner-cavity or down-port (within the context of aport-based procedure) images. For example, such down-port orinner-cavity real-time visible intraoperative imaging may allow for thereal-time capture of otherwise obscured or challenging inner-cavityviews.

Still referring to FIG. 7, alternatively, or in combination therewith,the tracked tool tip may be sensored with one or more sensors, e.g.,micro-sensors, such as a pressure sensor or the like to capture distinctor further inner-cavity or down-port characterizations otherwiseunavailable. For example, a tracked displaceable down-port orinner-cavity pressure sensor may allow for the effective location of anobscured bleeding site, for example, which can then be more effectivelyaddressed, e.g., via bipolar or other method, as compared to currentmethods, which generally require a blind or mostly obscured visualextra-cavity assessment. These examples will be expanded on furtherbelow, with reference to specific embodiments.

Referring back to FIG. 3, a sensored surgical tool, e.g., a tool 1500,generally comprises a rigid elongate tool body 1502 having asubstantially rigid tool tip 1504. In this embodiment, the tip 1504forms part of a detachable/disposable sensored tool tip portion 1506 andis operatively coupled partway up the tool body 1502, e.g., with a toolshaft or rod 1503. The tool shaft 1503 integrally leads to a tool bodyhandle 1508 and tracking portion, such as tracking marker tree 1510encompassing a set of configurationally and recognizably predisposedtracking markers 1512, e.g., fiducial markers, such as those describedand shown in relation to FIGS. 6A-6D.

Still referring back to FIG. 3, for instance, the tool's tracking markertree 1510 comprises a set of tracking markers 1512 rigidly mounted in adistinctly recognizable geometric configuration via a designated supportstructure, e.g., an instrument-specific marker configuration and/or typefor automated tool type recognition and comprehensive real-timetracking/display. The various tracking techniques, marker types andconfigurations described above are equally applicable in this example.

Still referring back to FIG. 3, the tool's body handle 1508 isconfigured and adapted for its intended use, either for manual operationor for guided or automated operation by a robotic arm or the like, thatis, amenable for operative coupling to a robotic arm coupler, grip orclasp, as the case may be. In this particular example, the body handle1508 and tracking portion 1510 are shaped and oriented relative to thetool body shaft 1503 and tip portion 1506 so to remain visible to thetracking system, e.g., optical tracking system 213, as shown in FIG. 2,and related overhead camera(s), while limiting a potential obstructionthereof to the external scope and/or cameras, e.g., so not to overlyobstruct a surgeon's external overhead view angles. These and othertracking portion configurations, as shown in FIGS. 6A-6D, may beconsidered.

Referring back to FIGS. 4A and 4B, the detachable/disposable tip portion1506 comprises one or more tool tip sensors, the tool tip sensorscomprising one or more imaging sensors, such as cameras 1516, one ormore pressure sensors 1518, or like pressure-sensitive transducers. Eachcamera and/or sensor is operatively mounted at or near the tip 1504 tocapture inner-cavity images and/or measurements, respectively, which canbe relayed in real-time, in this embodiment, via respective embeddedwiring 1520 and corresponding contacts 1521, e.g., quick connect contactpoints, operatively disposed on the detachable tip portion 1506 tocooperate with corresponding contacts (not shown) and wiring on thereusable tool body shaft 1503 (FIG. 3). Different types of contacts 1521may be considered, such as pressure-fitting or magnetized contacts, oragain touch contact spots solidly connected via a cooperative engagementor coupling linking the removable tip portion 1506 and tool body shaft1503, e.g., snap coupling, pressure-fitted coupling, mating engagementfitting, etc. These and other contact and component coupling techniquesis readily applied within the context of the illustrated embodimentwithout departing from the general scope and nature of the presentdisclosure. Likewise, while distinct “four-channel” contacts areillustrated to communicatively link the various tool tip sensors to theRF transmitter via respective wiring, different signaling configurationsare also be encompassed, such as joint cabling and connectorconfigurations, as well as multiplexing data channeling configurationsrelying, at least in part, on tip-based data preprocessing andcommunication hardware, for example.

Still referring back to FIGS. 4A and 4B, while not explicitlyillustrated, appropriate power can also be delivered to the sensors, asappropriate, to operate same. Likewise, an appropriate illuminationsource, such as a miniature LED light source or the like, may bedirectly mounted at, near or in relation to the tip, or the illuminationthereof relayed thereto via an appropriate waveguide or fiber, asneeded, and as will be readily appreciated by the skilled artisan, toprovide appropriate illumination for image capture if such illuminationis not sufficiently available from external illumination sources.

Referring back to FIGS. 3, 4A, and 4B, in the illustrated embodiment,the embedded wiring is routed to a wireless communication device, forinstance comprising a radio frequency (RF) antenna 1522 and RF circuitry1524 operable to relay data signals produced by the tip sensor(s) 1516,1518 to a corresponding RF receiver and antenna 1526 associated with a(wireless) input/output (I/O) device and interface 1527 and relatedcommunication interface(s) 1528 of the surgical system's control andprocessing unit 1530, or a subcomponent or module thereof, for example.

Still referring back to FIGS. 3, 4A, and 4B, for instance, sensor datasignals can be processed, e.g., via processor 1532 and memory 1534 ofthe processing unit 1530, in conjunction with the system'stracking/navigation system 1536 and related image processing and displayfunctions, e.g., schematically depicted as display submodule 1538, inreal-time for display alone or in combination with one or more otherprocedure-related visualizations, e.g., preoperative and/orintraoperative image overlays, pressure data mappings and/orlocalizations, etc. Tool tip inner-cavity imaging and/or pressurecharacterizations are externally communicated via the illustrated wiring1520 and RF communication hardware 1524, 1522, or again via other director indirect communication means, such as via one or more electrical,optical and/or wireless data relays, and the like, embedded or,otherwise, operatively coupled with the sensored tool 1500.

Still referring back to FIGS. 3, 4A, and 4B, the detachable tool tipportion 1506 comprises a rigid, e.g., metal or plastic, sheath 1542within which the sensor wiring 1520 is embedded or relayed, and whichforms the surface of the tip 1504 that interfaces with the patient'sinner-cavity, e.g., down-port, tissues/fluids. Embedded within, on,and/or through this sheath 1542 toward the tip 1504, e.g., on or atleast partly embedded within or through a laterally, or mostlylaterally, oriented surface of the sheath tip portion 1506 at or towardthe tip 1504, are located the camera(s) 1516 and/or pressure sensor(s)1518 in operative connection with their respective wiring 1520.

Still referring back to FIGS. 3, 4A, and 4B, the tip portion 1506includes two cameras 1516 juxtaposed lengthwise along and toward the tip1504 such that the camera closest to the tip 1504 is angled (A)longitudinally/downwardly, e.g., toward a cavity bottom in operation,relative to the camera farthest from the tip 1504. This configurationallows, in some examples, for distinct inner cavity intraoperative viewangles that can, when processed, provide different down-cavityview-points to enhance visibility and a visual explorative imagingcapacity of the sensored tool 1500 (FIG. 3), and/or be combined toconstruct, or contribute to the construction of, a 3D intraoperativedown-cavity image. For example, one camera of the cameras isparticularly oriented to capture surgical cavity sidewall images,whereas the other camera of the cameras seeks to predominantly capturecavity bottom views. In some examples, images captured from respectivetip cameras can be stitched together to enlarge a field of view of thecavity sidewall. In different embodiments, the two cameras may bejuxtaposed side-by-side, on opposite sides of the tip 1504, or consistof a single tip camera, to name a few examples.

Still referring back to FIGS. 3, 4A, and 4B, the tip portion 1506further includes at least one, and in this case two, pressure sensors1518, one disposed on either side of the longitudinally disposed cameras1516. Again, distinct pressure readings may be used to providedistinctly localized pressure readings, combined to provide an averagereading corresponding to a general location of the tip 1504, or usedand/or processed in different combinations, such as to compute real-timelocalized pressure gradients and/or variations, to name a few examples.A pressure sensor array may also be used to further enhance pressurereading versatility. As for the images relayed from the cameras 1516,pressure readings are used to pinpoint localized pressure readings ofinterest, e.g., anomalously high pressure readings, such ascorresponding to a bleeding site or the like, sharp pressure gradientsleading to anomalous down-cavity issues, again such as a bleeding site,etc., or again generate a localized down-cavity pressure mapping, withsuch results ultimately displayable alone or in concert with otherpreoperative and/or intraoperative images, readings and/or measurements.Again, while two pressure sensors 1518 are shown, a single pressuresensor or a plurality of pressure sensors in varying configurations maybe used to enhance pressure readings and sensory data complexity. Forexample, a pressure sensor array is used to more accurately map pressurevariations within the cavity and, thus, more readily pinpoint a bleedingsite, e.g., from a vein or artery hole, for example, or other anomalouspressure point.

Still referring back to FIGS. 3, 4A, and 4B, various cameras areamenable for use in the embodiments of the present disclosure, providedthat such various cameras have a sufficiently small footprint toaccommodate the size and area available at the tool tip 1504. Forexample, a complementary metal oxide semiconductor (CMOS) camera with anintegrated micro lens is particularly amenable for use in embodiments ofthe present disclosure to generate high-resolution inner cavity images.For example, the minimal form factor image sensor NanEye 2D by Awaiba®(http://www.cmosis.com/products/product_detail/naneye) provides oneexample of a system on a chip camera having a footprint of approximately1 mm². For a tool tip portion having a diameter in a range ofapproximately 4 mm to approximately 5 mm, a camera footprint of thisorder is suitable, even when combining two cameras and two pressuresensors in the same tip area. Clearly, where a single camera is used, alarger footprint, for example in a range of at least approximately 4 mm²is suitable.

Still referring back to FIGS. 3, 4A, and 4B, furthermore, each of theone or more cameras may consist of self-contained camera units, thuscomprising any and all circuitry to implement the camera and captureimages, e.g., pixelated/digital images, therewith, as well as anynecessary optics, e.g., micro lens, integrally formed therewith. Inother embodiments, additional components, such as external lenses or thelike, may be provided, for example within the sheath illustrated herein,or again, as an add-on component, to provide a desired imaging effect.Generally, the camera(s) will be sealed in a waterproof configuration toensure proper operation within the surgical environment and reduce thelikelihood of camera failures. Likewise, while identical thoughdistinctly oriented cameras are shown in the illustrated embodiments,different camera characteristics may be considered to providecomplementary effects, e.g., narrow angle lens vs. wide angle lens,different image spectrum sensitivity such as narrow band vs. broadbandand/or visible vs. near infrared cameras, etc. Furthermore, while notexplicitly illustrated, the sensored tip further comprises an integratedillumination device, such as a miniature LED light source or the like toprovide required or complementary, e.g., complementary to externalillumination, inner-cavity illumination for effective image capture. Inyet another example, the tool further comprises a directional lightsource such as a laser light source to gauge a distance to the imaged orcharacterized tissue by measuring reflected laser light travel times,for example.

Still referring back to FIGS. 3, 4A, and 4B, likewise, differentpressure sensor technologies may be invoked to provide an appropriatetool tip sensor. For example, different Fabry-Perot, piezoresistive,nanotube and/or optical microelectromechanical (MEMS) pressure sensorsmay be amenable to the herein-described application. Examples of suchsensors are respectively described by G. C. Hill, et al. 2007, SU-8 MEMSFabry-Perot pressure sensor, Sensors and actuators A 138(2007) 52-62;Jialin Yao, et al., 2016, A flexible and highly sensitive piezoresistivepressure sensor based on micropatterned films coated with carbonnanotubes, Journal of Nanomaterials, Volume 2016; and Yixian Ge, et al.,An optical MEMS pressure sensor based on a phase demodulation method,Sensors and actuators A 143(2008) 224-229; the entire contents of eachof which are hereby incorporated herein by reference. Other pressuresensor types may also be considered, without departing from the generalscope and nature of the present disclosure.

Still referring back to FIGS. 3, 4A, and 4B, as noted above, othersurgical tools are effectively sensored and tracked by the surgicalsystem's tracking hardware to provide enhanced inner cavitycharacterization and/or imaging. For example, a suction tool is usedwhen the surgical cavity is immersed in blood or fluid in order to seekout a bleeding or leaking site to be addressed. Accordingly, suchsuction tool may be advantageously fitted with one or more camerasand/or pressure sensors, as noted above, to improve inner cavityassessment while using the tracked suction tool. Much like the pointingtool described herein, the suction tool comprises a sensored tip, e.g.,laterally oriented sensors operatively mounted on an axially or opposinglaterally directed suction tool. Alternatively, the suction tool may becombined with a distinct pointing tool portion, much as described above,to provide dual functions. Such as described above, a suction tool tipportion may consist of a disposable tip portion that may be replaced foreach new procedure. Other surgical tools may equally benefit from sensorborne tool tips as described above, not only to improved inner cavityimaging/characterization intraoperatively, but also to acceleratecertain surgical site processes by accurately imaging, locating andmapping inner cavity characteristics to be addressed or considered inreal-time during the surgical procedure.

Referring back to FIG. 3, the illustrative control and processing unit1530, which may consist of a standalone or subcomponent of an overallsurgical system processing and control unit, may include, but is notlimited to comprising one or more processors 1532 (for example, aCPU/microprocessor or a graphical processing unit, or a combination of acentral processing unit or graphical processing unit), bus 1544, memory1534, which may include random access memory (RAM) and/or read onlymemory (ROM), one or more internal storage devices 1546, e.g., a harddisk drive, compact disk drive or internal flash memory, a power supply1548, one more communications interfaces 1528, optional external storage1550, display image/data processing 1538, and one or more input/outputdevices and/or interfaces 1527, e.g., a wireless receiver/transmitterand antenna 1526, a speaker, a display, e.g., one or more displays 205,211, as shown in FIG. 2, and/or a linked graphical user interface (GUI)or the like), an imaging sensor, such as those used in a digital stillcamera or digital video camera, a clock, an output port, a user inputdevice, such as a keyboard, a keypad, a mouse, a position trackedstylus, a foot switch, and/or a microphone for capturing speechcommands).

Still referring back to FIG. 3, the control and processing unit 1530 isprogrammed with programs, subroutines, applications or modules, whichinclude executable instructions, which when executed by the processor,causes the system to perform one or more methods described in thedisclosure. Such instructions may be stored, for example, in memory 1534and/or internal storage 1546. In particular, in the exemplary embodimentshown, image processing module 1538 includes computer executableinstructions for analyzing output tool tip sensor data (images and/orpressure readings). For example, computer readable instructions may beprovided for processing image and/or pressure data obtained at differentinner-cavity spatial locations and tool tip orientations in order toimage/characterize otherwise potentially obscured regions of thesurgical cavity. The spatial location/orientation may be correlated withthe recorded image/pressure data via the tracking of the position andorientation of tool 1500, for instance tracked via illustrated trackingand navigation module 1536. For example, the tracking and navigationmodule 1536 may include executable instructions for processing trackingdata, and/or for rendering a navigation user interface on a display, asabove discussed.

Still referring back to FIG. 3, although only one of each unit componentis illustrated, any number of each component can be included in thecontrol and processing unit 1530. For example, a computer typicallycontains a number of different data storage media. Furthermore, althoughthe bus 1544 is depicted as a single connection between all of thecomponents, the bus 1544 may represent one or more circuits, devices, orcommunication channels which link two or more of the components. Forexample, in personal computers, the bus 1544 often includes or is amotherboard. Control and processing unit 1530 may include many more orless components than those shown. One or more external subsystems, suchas a tool tip sensor data processing device, may be distinctlyimplemented and communicatively linked to an overall surgical systemcontrol and processing unit, or form an integral part thereof.

Still referring back to FIG. 3, in one embodiment, the control andprocessing unit 1530 may be, or include, a general purpose computer orany other hardware equivalents. The control and processing unit 1530 mayalso be implemented as one or more physical devices that are coupledwith the processor 1532 through one of more communications channels orinterfaces. For example, the control and processing unit 1530 isimplemented using application specific integrated circuits (ASICs).Alternatively, control and processing unit 1530 is implemented as acombination of hardware and software, where the software is loaded intothe processor from the memory or over a network connection.

Referring to FIG. 8, this schematic diagram illustrates a relationshipamong components of an overall surgical navigation system 200, such as acontrol and processing unit 400, a tracking system 213, a data storagedevice 442 for the tracking system 213, and system devices 420, andmedical instruments 460, and medical tools, in accordance with anembodiment of the present disclosure. The control and processing unit400 comprises at least one processor 402, a memory 404, such as anon-transitory memory device, a system bus 406, at least oneinput/output interface 408, a communications interface 410, and storagedevice 412. The control and processing unit 400, which may encompass orinterface with control and processing unit 1530, as shown in FIG. 3, isinterfaced with other external devices, such as the tracking system 213,the data storage device 442 for the tracking system 213, and theexternal user input and output devices 444, optionally comprising, forexample, at least one of a display device, such as display devices 211,205, a keyboard, a mouse, a foot pedal, a microphone, and a speaker.

Still referring to FIG. 8, the data storage 442 comprises any suitabledata storage device, such as a local or remote computing device, e.g., acomputer, hard drive, digital media device, or server, having a databasestored thereon. The data storage device 442 stores identification data450 for identifying at least one medical instrument 460 andconfiguration data 452 for associating customized configurationparameters with at least one medical instrument 460. The data storagedevice 442 further stores at least one of preoperative image data 454and medical procedure planning data 456. Although the data storagedevice 442 is shown as a single device, in other embodiments, the datastorage device 442 comprises multiple storage devices. The data storagedevice 442 is also configured to store data in a custom data structurecorresponding to various 3D volumes at different resolutions, whereineach may be captured with a unique time-stamp and/or quality metric.This custom data structure provides the system 200 (FIGS. 1 and 2) withan ability to move through contrast, scale, and time during the surgicalprocedure.

Still referring to FIG. 8, the medical instruments (tools) 460 areidentifiable by the control and processing unit 400, wherein the medicalinstruments 460 are coupled with, and controlled by, the control andprocessing unit 400. Alternatively, the medical instruments 460 areoperable or otherwise independently employable without the control andprocessing unit 400. The tracking system 213 may be employed to track atleast one of the medical instruments 460 and spatially register the atleast one medical instrument 460 in relation to an intraoperativereference frame. The tracking system 213, thus, furnishes the requisiteposition, orientation, and location data to associate sensored tool datawith corresponding locations within the surgical cavity.

Still referring to FIG. 8, the control and processing unit 400 is alsointerfaceable with a number of configurable devices, andintraoperatively reconfigure at least one such device based onconfiguration parameters obtained from configuration data 452. Examplesof devices 420 include, but are not limited to, at least one externalimaging device 422, at least one illumination device 424, robotic arm202, at least one projection device 428, and at least one displaydevice, such as display devices 211, 205.

Still referring to FIG. 8, the control and processing unit 400 isoperable by the at least one processor 402 and the at least one memory404. For example, the functionalities described herein are at leastpartially implemented via hardware logic in processor 402 by way of theinstructions stored in memory 404 though at least one processing engine470. Examples of processing engines 470 include, but are not limited to,user interface engine 472, tracking engine 474, motor controller 476,image processing engine 478, image registration engine 480, procedureplanning engine 482, navigation engine 484, and context analysis module486.

Still referring to FIG. 8 and referring back to FIGS. 1 and 2,understood is that the system 200 is not intended to be limited to thecomponents shown in the several figures of the Drawing. One or morecomponents of the control and processing 400 may be provided as anexternal component or device. In an alternative embodiment, thenavigation module 484 is provided as an external navigation system thatis integrated with the control and processing unit 400. Embodiments ofthe system 200, as shown in FIG. 2, may be implemented by using theprocessor 402 without additional instructions stored in the memory 404.Embodiments may also be implemented, using the instructions stored inthe memory 404, for execution by one or more general purposemicroprocessors.

Referring to FIG. 9, this schematic diagram illustrates a preoperativesurgical planning system 900 for use with a navigation system 200, inaccordance with an embodiment of the present disclosure. Thepreoperative surgical planning system 900 comprises components andinputs for planning and scoring surgical paths.

Referring to FIG. 10, this schematic diagram illustrates anintraoperative surgical management system 1000 for use with a navigationsystem 200, in accordance with an embodiment of the present disclosure.The intraoperative surgical management system 1000 comprises componentsand inputs for navigation along the surgical paths produced by thepreoperative surgical planning system 900, as shown in FIG. 9. Theintraoperative surgical management system 1000 are used as a surgicalplanning and navigation tool in the preoperative and intraoperativestages. Data input(s) of the surgical planning steps and surgicalprocedures, as shown in FIG. 9, are used as input(s) to theintraoperative navigation stage performable by the intraoperativesurgical management system 1000.

Still referring to FIG. 10, the intraoperative surgical managementsystem 1000 of the navigation system 200 provides a user, such as asurgeon, with a unified technique for navigating through a surgicalregion by utilizing preoperative data input(s) and updatedintraoperative data input(s). The processor(s), such as the at least oneprocessor 402, is operable by way of a set of instructions and/oralgorithms storable in relation to a non-transitory memory device, suchas the at least one memory 404, wherein the at least one processor 402is configured to: analyze preoperative data input(s) and intraoperativedata input(s) and update surgical plans during the course of surgeryaccordingly.

Still referring to FIG. 10, for example, if intraoperative input(s) inthe form of newly acquired images identified a previously unknown orunidentified nerve bundle or a previously unknown or unidentified fibertrack, the at least one processor 402 can use these intraoperativeinput(s), if desired, for updating the surgical plan during surgery toavoid contacting the nerve bundle. The intraoperative input(s) mayinclude a variety of input(s), including local data gathered using avariety of sensor(s), such as at least one intraoperative imaging sensor(not shown). In some embodiments, the intraoperative surgical managementsystem 1000 of the navigation system 200 may provide continuouslyupdated, e.g., in real-time, intraoperative input(s) in the context of aspecific surgical procedure by way of the at least one intraoperativeimaging sensor to: validate tissue position, update tissue imaging aftertumor resection, and update surgical device position during surgery.

Still referring to FIG. 10, the intraoperative surgical managementsystem 1000 of the navigation system 200 may provide for re-formattingof the image, for example, to warn of possible puncture of, or collisionwith, critical tissue structures with a surgical tool during surgery. Inaddition, the intraoperative surgical management system 1000 may provideimaging and input updates for any shifts or surgical errors that mightoccur from a needle deflection, tissue deflection, or patient movementas well as provide analysis and transformation of data to correct forimaging distortions, e.g., in real-time. The magnitude of these combinedshifts or surgical errors is clinically significant and may regularlyexceed 2 cm. Some of the most significant distortions are magneticresonance imaging (MRI) based distortions such as gradientnon-linearity, susceptibility shifts, and eddy current artifacts, whichmay exceed 1 cm on standard MRI scanners (1.5 T and 3.0 T systems). Theintraoperative surgical management system 1000 mitigates, and mayeliminate, these combined shifts or surgical errors.

Still referring to FIG. 10, in accordance with some embodiments of thepresent disclosure, by using the intraoperative surgical managementsystem 1000, a variety of intraoperative imaging techniques areimplemented to generate intraoperative input(s) by way of a variety ofimaging devices, including anatomy specific MRI devices, surface arrayMRI scans, endo-nasal MRI devices, anatomy specific ultrasound (US)scans, endo-nasal US scans, anatomy specific computerized tomography(CT) or positron emission tomography (PET) scans, port-based or probebased photo-acoustic imaging, sensored tool imaging and/orcharacterization, as well as optical imaging done with remote scanning,or probe based scanning, whereby multi-modal imaging and data areprovidable and transformable into useful images and data in real-time.

Referring back to FIGS. 1-4B, these diagrams, together, illustrate asurgical tool 1500, operable with an external data processing unit,e.g., the control and processing unit 1530, for use within an opensurgical cavity (not shown), in accordance with an embodiment of thepresent disclosure. The surgical tool 1500 comprises: a medicalinstrument of the medical instruments 460, e.g., a rigid elongate toolbody 1502 comprising a substantially rigid tool tip 1504 configured tobe displaced and tracked within the open surgical cavity forreproducibly locating the substantially rigid tool tip 1504 within theopen surgical cavity, the rigid elongate tool body 1502 configured tooperate with at least one pressure sensor, e.g., of the pressure sensors1518, at least one camera, e.g., of the cameras 1516, and the externaldata processing unit, e.g., the control and processing unit 1530; andanother medical instrument of medical instruments 460, e.g., a suctiontool comprising a suction tool tip portion, the suction tool configuredto operate with at least one other pressure sensor, e.g., of thepressure sensors 1518, at least one other camera, e.g., of the cameras1516, and the external data processing unit, e.g., the control andprocessing unit 1530, wherein imaging, locating, and mapping innercavity characteristics are considered by the external data processingunit, e.g., the control and processing unit 1530, in real-time during asurgical procedure, the external data processing unit, e.g., the controland processing unit 1530, operable to: associate at least one pressurereading, corresponding to at least one sensor signal from the at leastone pressure sensor, e.g., of the pressure sensors 1518, with at leastone location of each at least one pressure sensor, e.g., of the pressuresensors 1518, within the open surgical cavity; associate at least onepressure reading, corresponding to at least one sensor signal from theat least one other pressure sensor, e.g., of the pressure sensors 1518,with at least one location of each at least one other pressure sensor,e.g., of the pressure sensors 1518, within the open surgical cavity; andassociate at least one respective inner-cavity image, e.g., the images205 a, 211 a, with at least one location of the substantially rigid tooltip 1504 and at least one location of the suction tool tip portion.

Still referring back to FIGS. 1-4B, the surgical tool 1500 furthercomprises the at least one camera, e.g., of the cameras 1516, the atleast one camera disposed, and laterally-oriented, along the rigidelongate tool body 1502 in one of at the substantially rigid tool tip1504 and proximate the substantially rigid tool tip 1504 to capture atleast one lateral image (not shown) from within the open surgical cavity(not shown), the at least one lateral image externally communicable toassociate at least one respective inner-cavity image with the at leastone location of the substantially rigid tool tip 1504, and the at leastone camera, e.g., of the cameras 1516, operable in a near-infraredwavelength range.

Still referring back to FIGS. 1-4B, the surgical tool 1500 furthercomprises the at least one pressure sensor, e.g., of the pressuresensors 1518, the at least one pressure sensor operatively disposedalong the rigid elongate tool body 1502 at a position in one of at thesubstantially rigid tool tip 1504 and proximate the substantially rigidtool tip 1504, the pressure sensor responsive to pressure variationsapplied thereto from within the open surgical cavity to output a sensorsignal representative thereof as the substantially rigid tool tip 1504is displaced within the open surgical cavity, the sensor signalexternally communicable to associate respective inner-cavity pressurereadings with locations of the substantially rigid tool tip 1504. Thesurgical tool 1500 further comprises a set of fiducial markers, e.g.,the tracking markers 1512, externally coupled in a fixed configurationto an externally extending portion of the rigid elongate tool body 1502,the markers trackable by an external tracking system, e.g., the trackingand navigation module 1536, to automatically determine the at least onelocation of the substantially rigid tool tip 1504, with reference to theopen surgical cavity, based on a respective tracked position of the setof fiducial markers, e.g., the tracking markers 1512. The surgical tool1500 further comprises a radio frequency transmitter to wirelesslycommunicate the sensor signal, e.g., via a wireless receiver/transmitterand antenna 1526.

Still referring back to FIGS. 1-4B, the pressure sensor, e.g., of thepressure sensors 1518, is laterally oriented relative to thesubstantially rigid tool tip 1504. In some embodiments, the pressuresensor, e.g., of the pressure sensors 1518, comprises at least one of: aFabry-Perot pressure sensor, a piezoresistive pressure sensor, nanotubepressure sensor, and an optical microelectromechanical (MEMS) pressuresensor. In some embodiments, the pressure sensor comprises a pluralityof pressure sensors disposed at a position in one of: at thesubstantially rigid tool tip 1504 and proximate the substantially rigidtool tip 1504. In some embodiments, the pressure sensor comprises aplurality of pressure sensors collocated at a position in one of: at thesubstantially rigid tool tip and toward the substantially rigid tooltip.

Still referring back to FIGS. 1-4B, in the surgical tool 1500, at leastone of: the suction tool tip portion comprises a disposable tip portion;the suction tool is disposed at a position, in one of: at thesubstantially rigid tool tip 1504 and proximate the substantially rigidtool tip 1504, to concurrently provide suction within the surgicalcavity around the substantially rigid tool tip 1504; at least oneexternal camera is configured to align with, and view, the open surgicalcavity, and the substantially rigid tool tip 1504 is operable as atrackable pointer within the open surgical cavity.

Still referring back to FIGS. 1-4B, the surgical tool 1500 furthercomprises at least one complementary camera disposed along the rigidelongate tool body 1502 at a position, in one of at the substantiallyrigid tool tip 1504 and proximate the substantially rigid tool tip 1504,to capture complementary images of the open surgical cavity along acomplementary imaging axis angled toward a cavity bottom relative to atleast one camera, e.g., of the cameras 1516, to construct one of a 3Dinner-cavity mapping and an enlarged field of view image of the opensurgical cavity from the at least one lateral image and thecomplementary images.

Still referring back to FIGS. 1-4B, at least one of the at least oneexternal camera and a scope is configured to align with, and view, theopen surgical cavity. The at least one inner-cavity image iscomplementary to at least one external image captured by at least one ofthe at least one external camera and the scope in enhancing inner-cavityvisualization. The substantially rigid tool tip 1504 is movable withinthe open surgical cavity to track at last one pressure variationresulting from inner-cavity bleeding in locating a bleeding site withinthe open surgical cavity. The rigid elongate tool body 1502 comprises areusable tool shaft portion and a disposable tool tip portion removablyoperatively connectable to the shaft portion. The disposable tool tipportion comprises the substantially rigid tool tip 1504 and the pressuresensor, e.g., of the pressure sensors 1518.

Referring to FIG. 11, this flow diagram illustrates a method M1 ofproviding a surgical tool 1500, operable with an external dataprocessing unit, e.g., the control and processing unit 1530, for usewithin an open surgical cavity (not shown), in accordance with anembodiment of the present disclosure. The method M1 comprises: providinga medical instrument of the medical instruments 460, e.g., a rigidelongate tool body 1502, comprising a substantially rigid tool tip 1504configured to be displaced and tracked within the open surgical cavityfor reproducibly locating the substantially rigid tool tip 1504 withinthe open surgical cavity, the rigid elongate tool body 1502 configuredto operate with at least one pressure sensor, e.g., of the pressuresensors 1518, at least one camera, e.g., of the cameras 1516, and theexternal data processing unit, e.g., the control and processing unit1530, as indicated by block 1101; and providing another medicalinstrument of medical instruments 460, e.g., a suction tool comprising asuction tool tip portion, the suction tool configured to operate with atleast one other pressure sensor, e.g., of the pressure sensors 1518, atleast one other camera, e.g., of the cameras 1516, and the external dataprocessing unit, e.g., the control and processing unit 1530, asindicated by block 1102, wherein imaging, locating, and mapping innercavity characteristics are considered by the external data processingunit, e.g., the control and processing unit 1530, in real-time during asurgical procedure, the external data processing unit, e.g., the controland processing unit 1530, operable to: associate at least one pressurereading, corresponding to at least one sensor signal from the at leastone pressure sensor, e.g., of the pressure sensors 1518, with at leastone location of each at least one pressure sensor, e.g., of the pressuresensors 1518, within the open surgical cavity; associate at least onepressure reading, corresponding to at least one sensor signal from theat least one other pressure sensor, e.g., of the pressure sensors 1518,with at least one location of each at least one other pressure sensor,e.g., of the pressure sensors 1518, within the open surgical cavity; andassociate at least one respective inner-cavity image, e.g., the images205 a, 211 a, with at least one location of the substantially rigid tooltip 1504 and at least one location of the suction tool tip portion.

Still referring to FIG. 11, the method M1 further comprises providingthe at least one camera, e.g., of the cameras 1516, providing the atleast one camera comprising disposing, and laterally-orienting, the atleast one camera along the rigid elongate tool body 1502 in one of atthe substantially rigid tool tip 1504 and proximate the substantiallyrigid tool tip 1504 to capture at least one lateral image from withinthe open surgical cavity, the at least one lateral image externallycommunicable to associate at least one respective inner-cavity image,e.g., the images 205 a, 211 a, with the at least one location of thesubstantially rigid tool tip 1504, and the at least one camera operablein a near-infrared wavelength range, as indicated by block 1103.

Still referring to FIG. 11, the method M1 further comprises providingthe at least one pressure sensor, e.g., of the pressure sensors 1518,providing the at least one pressure sensor comprising operativelydisposing the at least one pressure sensor along the rigid elongate toolbody 1502 at a position in one of at the substantially rigid tool tip1504 and proximate the substantially rigid tool tip 1504, the pressuresensor responsive to pressure variations applied thereto from within theopen surgical cavity to output a sensor signal representative thereof asthe substantially rigid tool tip 1504 is displaced within the opensurgical cavity, the sensor signal externally communicable to associaterespective inner-cavity pressure readings with locations of thesubstantially rigid tool tip 1504, as indicated by block 1104.

Still referring to FIG. 11, the method M1 further comprises providing aset of fiducial markers, e.g., the tracking markers 1512, externallycoupled in a fixed configuration to an externally extending portion ofthe rigid elongate tool body 1502, the markers trackable by an externaltracking system, e.g., the tracking and navigation module 1536, toautomatically determine the at least one location of the substantiallyrigid tool tip 1504, with reference to the open surgical cavity, basedon a respective tracked position of the set of fiducial markers, e.g.,the tracking markers 1512, as indicated by block 1105. The method M1further comprises providing a radio frequency transmitter to wirelesslycommunicate the sensor signal, as indicated by block 1106.

Still referring to FIG. 11, in the method M1, at least one of: providingthe at least one pressure sensor, e.g., of the pressure sensors 1518, asindicated by block 1104, comprises laterally orienting the at least onepressure sensor relative to the substantially rigid tool tip; providingthe at least one pressure sensor, e.g., of the pressure sensors 1518, asindicated by block 1104, comprises providing at least one of: aFabry-Perot pressure sensor, a piezoresistive pressure sensor, nanotubepressure sensor, and an optical microelectromechanical (MEMS) pressuresensor; providing the at least one pressure sensor, e.g., of thepressure sensors 1518, as indicated by block 1104, comprises providing aplurality of pressure sensors disposed at a position in one of: at thesubstantially rigid tool tip 1504 and proximate the substantially rigidtool tip 1504; providing the at least one pressure sensor, e.g., of thepressure sensors 1518, as indicated by block 1104, comprises collocatinga plurality of pressure sensors 1518 at a position in one of: at thesubstantially rigid tool tip 1504 and toward the substantially rigidtool tip 1504; providing another medical instrument of medicalinstruments 460, e.g., a suction tool, as indicated by block 1102,comprises providing the suction tool tip portion as a disposable tipportion, providing another medical instrument of medical instruments460, e.g., a suction tool, as indicated by block 1102, comprisesdisposed the suction tool at a position, in one of: at the substantiallyrigid tool tip 1504 and proximate the substantially rigid tool tip 1504,to concurrently provide suction within the surgical cavity around thesubstantially rigid tool tip 1504; providing the at least one camera,e.g., of the cameras 1516, as indicated by block 1103, comprisesproviding at least one external camera configured to align with, andview, the open surgical cavity; and providing the medical instrument ofthe medical instruments 460, e.g., a rigid elongate tool body 1502,comprises providing the substantially rigid tool tip 1504 being operableas a trackable pointer within the open surgical cavity, the at least oneexternal camera and a scope is configured to align with, and view, theopen surgical cavity, the at least one inner-cavity image iscomplementary to at least one external image captured by at least one ofthe at least one external camera and the scope in enhancing inner-cavityvisualization, the substantially rigid tool tip 1504 is movable withinthe open surgical cavity to track at last one pressure variationresulting from inner-cavity bleeding in locating a bleeding site withinthe open surgical cavity, the rigid elongate tool body 1502 comprises areusable tool shaft portion and a disposable tool tip portion removablyoperatively connectable to the shaft portion, and the disposable tooltip portion comprises the substantially rigid tool tip 1504 and thepressure sensor 1518.

Still referring to FIG. 11, the method M1 further comprises providing atleast one complementary camera, providing the at least one complementarycamera comprising disposing the at least one complementary camera alongthe rigid elongate tool body 1502 at a position, in one of at thesubstantially rigid tool tip 1504 and proximate the substantially rigidtool tip 1504, to capture complementary images of the open surgicalcavity along a complementary imaging axis angled toward a cavity bottomrelative to at least one camera to construct one of a 3D inner-cavitymapping and an enlarged field of view image of the open surgical cavityfrom the at least one lateral image and the complementary images, asindicated by block 1107.

Referring to FIG. 12, this flow diagram illustrates a method M2 ofimaging, locating, and mapping inner cavity characteristics within anopen surgical cavity by way of a surgical tool 1500 operable with anexternal data processing unit, e.g., the control and processing unit1530, in accordance with an embodiment. The method M2 comprises:providing the surgical tool 1500, as indicated by block 1200, providingthe surgical tool 1500 comprising: providing a rigid elongate tool body1502 comprising a substantially rigid tool tip 1504 configured to bedisplaced and tracked within the open surgical cavity for reproduciblylocating the substantially rigid tool tip 1504 within the open surgicalcavity, the rigid elongate tool body 1502 configured to operate with atleast one pressure sensor, e.g., of the pressure sensors 1518, at leastone camera, e.g., of the cameras 1516, and the external data processingunit, e.g., the control and processing unit 1530, as indicated by block1201; and providing another medical instrument of medical instruments460, e.g., a suction tool comprising a suction tool tip portion, thesuction tool configured to operate with at least one other pressuresensor, e.g., of the pressure sensors 1518, at least one other camera,e.g., of the cameras 1516, and the external data processing unit, e.g.,the control and processing unit 1530, as indicated by block 1202; andconsidering imaging, locating, and mapping inner cavity characteristicsin real-time during a surgical procedure by the external data processingunit, e.g., the control and processing unit 1530, as indicated by block1203, considering comprising: associating at least one pressure reading,corresponding to at least one sensor signal from the at least onepressure sensor, e.g., of the pressure sensors 1518, with at least onelocation of each at least one pressure sensor, e.g., of the pressuresensors 1518, within the open surgical cavity, as indicated by block1204; associating at least one pressure reading, corresponding to atleast one sensor signal from the at least one other pressure sensor,e.g., of the pressure sensors 1518, with at least one location of eachat least one other pressure sensor, e.g., of the pressure sensors 1518,within the open surgical cavity, as indicated by block 1205; andassociating at least one respective inner-cavity image, e.g., the images205 a, 211 a, with at least one location of the substantially rigid tooltip 1504 and at least one location of the suction tool tip portion, asindicated by block 1206.

Thus, the present disclosure is not limited to a specific configurationof hardware, firmware, and/or software. While some embodiments can beimplemented in fully functioning computers and computer systems, variousembodiments are capable of being distributed as a computing product in avariety of forms and are capable of being applied regardless of theparticular type of machine or computer readable media used to actuallyeffect the distribution. At least some aspects disclosed can beembodied, at least in part, in software. That is, the techniques may becarried out in a computer system or other data processing system inresponse to its processor, such as a microprocessor, executing sequencesof instructions contained in a memory, such as ROM, volatile RAM,non-volatile memory, cache or a remote storage device. A computerreadable storage medium can be used to store software and data whichwhen executed by a data processing system causes the system to performvarious methods. The executable software and data may be stored invarious places including for example ROM, volatile RAM, nonvolatilememory and/or cache. Portions of this software and/or data may be storedin any one of these storage devices.

The preceding exemplary embodiments involve systems and methods in whicha device is intra-operatively configured based on the identification ofa medical instrument. In other example embodiments, one or more devicesmay be automatically controlled and/or configured by determining one ormore context measures associated with a medical procedure. A “contextmeasure”, as used herein, refers to an identifier, data element,parameter or other form of information that pertains to the currentstate of a medical procedure. In one example, a context measure maydescribe, identify, or be associated with, the current phase or step ofthe medical procedure. In another example, a context measure mayidentity the medical procedure, or the type of medical procedure, thatis being performed. In another example, a context measure may identifythe presence of a tissue type during a medical procedure. In anotherexample, a context measure may identify the presence of one or morefluids, such as biological fluids or non-biological fluids, e.g., washfluids, during the medical procedure, and may further identify the typeof fluid. Each of these examples relate to the image-basedidentification of information pertaining to the context of the medicalprocedure.

Examples of computer-readable storage media include, but are not limitedto, recordable and non-recordable type media such as volatile andnon-volatile memory devices, ROM, RAM, flash memory devices, floppy andother removable disks, magnetic disk storage media, optical storagemedia, e.g., compact discs (CDs), digital versatile disks (DVDs), etc.,among others. The instructions can be embodied in digital and analogcommunication links for electrical, optical, acoustical or other formsof propagated signals, such as carrier waves, infrared signals, digitalsignals, and the like. The storage medium may be the internet cloud, ora computer readable storage medium such as a disc.

At least some of the methods described herein are capable of beingdistributed in a computer program product comprising a computer readablemedium that bears computer usable instructions for execution by one ormore processors, to perform aspects of the methods described. The mediummay be provided in various forms such as, but not limited to, one ormore diskettes, compact disks, tapes, chips, USB keys, external harddrives, wire-line transmissions, satellite transmissions, internettransmissions or downloads, magnetic and electronic storage media,digital and analog signals, and the like. The computer usableinstructions may also be in various forms, including compiled andnon-compiled code.

While the present disclosure describes various embodiments forillustrative purposes, such description is not intended to be limited tosuch embodiments. On the contrary, the applicant's teachings describedand illustrated herein encompass various alternatives, modifications,and equivalents, without departing from the embodiments, the generalscope of which is defined in the appended claims. Except to the extentnecessary or inherent in the processes themselves, no particular orderto steps or stages of methods or processes described in this disclosureis intended or implied. In many cases the order of process steps may bevaried without changing the purpose, effect, or import of the methodsdescribed.

Information as herein shown and described in detail is fully capable ofattaining the above-described object of the present disclosure, thepresently preferred embodiment of the present disclosure, and is, thus,representative of the subject matter which is broadly contemplated bythe present disclosure. The scope of the present disclosure fullyencompasses other embodiments which may become apparent to those skilledin the art, and is to be limited, accordingly, by nothing other than theappended claims, wherein any reference to an element being made in thesingular is not intended to mean “one and only one” unless explicitly sostated, but rather “one or more.” All structural and functionalequivalents to the elements of the above-described preferred embodimentand additional embodiments are hereby expressly incorporated byreference and are intended to be encompassed by the present claims.

Moreover, no requirement exists for a system or method to address eachand every problem sought to be resolved by the present disclosure, forsuch to be encompassed by the present claims. Furthermore, no element,component, or method step in the present disclosure is intended to bededicated to the public, regardless of whether the element, component,or method step is explicitly recited in the claims. However, thatvarious changes and modifications in form, material, work-piece, andfabrication material detail may be made, without departing from thespirit and scope of the present disclosure, as set forth in the appendedclaims, are also encompassed by the disclosure.

What is claimed:
 1. A surgical tool, operable with an external dataprocessing unit, for use within an open surgical cavity, the surgicaltool comprising: a rigid elongate tool body comprising a substantiallyrigid tool tip configured to be displaced and tracked within the opensurgical cavity for reproducibly locating the substantially rigid tooltip within the open surgical cavity, the rigid elongate tool bodyconfigured to operate with at least one pressure sensor, at least onecamera, and the external data processing unit; and a suction toolcomprising a suction tool tip portion, the suction tool configured tooperate with at least one other pressure sensor, at least one othercamera, and the external data processing unit, wherein imaging,locating, and mapping inner cavity characteristics are considered by theexternal data processing unit in real-time during a surgical procedure,the external data processing unit operable to: associate at least onepressure reading, corresponding to at least one sensor signal from theat least one pressure sensor, with at least one location of each atleast one pressure sensor within the open surgical cavity; associate atleast one pressure reading, corresponding to at least one sensor signalfrom the at least one other pressure sensor, with at least one locationof each at least one other pressure sensor within the open surgicalcavity; and associate at least one respective inner-cavity image with atleast one location of the substantially rigid tool tip and at least onelocation of the suction tool tip portion.
 2. The surgical tool of claim1, further comprising the at least one camera, the at least one cameradisposed, and laterally-oriented, along the rigid elongate tool body inone of at the substantially rigid tool tip and proximate thesubstantially rigid tool tip to capture at least one lateral image fromwithin the open surgical cavity, the at least one lateral imageexternally communicable to associate at least one respectiveinner-cavity image with the at least one location of the substantiallyrigid tool tip, and the at least one camera operable in a near-infraredwavelength range.
 3. The surgical tool of claim 1, further comprisingthe at least one pressure sensor, the at least one pressure sensoroperatively disposed along the rigid elongate tool body at a position inone of at the substantially rigid tool tip and proximate thesubstantially rigid tool tip, the pressure sensor responsive to pressurevariations applied thereto from within the open surgical cavity tooutput a sensor signal representative thereof as the substantially rigidtool tip is displaced within the open surgical cavity, the sensor signalexternally communicable to associate respective inner-cavity pressurereadings with locations of the substantially rigid tool tip.
 4. Thesurgical tool of claim 1, further comprising a set of fiducial markersexternally coupled in a fixed configuration to an externally extendingportion of the rigid elongate tool body, the markers trackable by anexternal tracking system to automatically determine the at least onelocation of the substantially rigid tool tip, with reference to the opensurgical cavity, based on a respective tracked position of the set offiducial markers.
 5. The surgical tool of claim 1, further comprising aradio frequency transmitter to wirelessly communicate the sensor signal.6. The surgical tool of claim 3, wherein at least one of: the pressuresensor is laterally oriented relative to the substantially rigid tooltip, the pressure sensor comprises at least one of: a Fabry-Perotpressure sensor, a piezoresistive pressure sensor, nanotube pressuresensor, and an optical microelectromechanical (MEMS) pressure sensor,the pressure sensor comprises a plurality of pressure sensors disposedat a position in one of: at the substantially rigid tool tip andproximate the substantially rigid tool tip, and the pressure sensorcomprises a plurality of pressure sensors collocated at a position inone of: at the substantially rigid tool tip and toward the substantiallyrigid tool tip.
 7. The surgical tool of claim 1, wherein at least oneof: the suction tool tip portion comprises a disposable tip portion, andthe suction tool is disposed at a position, in one of: at thesubstantially rigid tool tip and proximate the substantially rigid tooltip, to concurrently provide suction within the surgical cavity aroundthe substantially rigid tool tip.
 8. The surgical tool of claim 1,wherein at least one of: at least one external camera is configured toalign with, and view, the open surgical cavity, and the substantiallyrigid tool tip is operable as a trackable pointer within the opensurgical cavity.
 9. The surgical tool of claim 2, further comprising atleast one complementary camera disposed along the rigid elongate toolbody at a position, in one of at the substantially rigid tool tip-andproximate the substantially rigid tool tip, to capture complementaryimages of the open surgical cavity along a complementary imaging axisangled toward a cavity bottom relative to at least one camera toconstruct one of a 3D inner-cavity mapping and an enlarged field of viewimage of the open surgical cavity from the at least one lateral imageand the complementary images.
 10. The surgical tool of claim 8, whereinat least one of the at least one external camera and a scope isconfigured to align with, and view, the open surgical cavity, andwherein the at least one inner-cavity image is complementary to at leastone external image captured by at least one of the at least one externalcamera and the scope in enhancing inner-cavity visualization.
 11. Thesurgical tool of claim 1, wherein the substantially rigid tool tip ismovable within the open surgical cavity to track at last one pressurevariation resulting from inner-cavity bleeding in locating a bleedingsite within the open surgical cavity.
 12. The surgical tool of claim 1,wherein the rigid elongate tool body comprises a reusable tool shaftportion and a disposable tool tip portion removably operativelyconnectable to the shaft portion, and wherein the disposable tool tipportion comprises the substantially rigid tool tip and the pressuresensor.
 13. A method of providing a surgical tool, operable with anexternal data processing unit, for use within an open surgical cavity,the method comprising: providing a rigid elongate tool body comprising asubstantially rigid tool tip configured to be displaced and trackedwithin the open surgical cavity for reproducibly locating thesubstantially rigid tool tip within the open surgical cavity, the rigidelongate tool body configured to operate with at least one pressuresensor, at least one camera, and the external data processing unit; andproviding a suction tool comprising a suction tool tip portion, thesuction tool configured to operate with at least one other pressuresensor, at least one other camera, and the external data processingunit, wherein imaging, locating, and mapping inner cavitycharacteristics are considered by the external data processing unit inreal-time during a surgical procedure, the external data processing unitoperable to: associate at least one pressure reading, corresponding toat least one sensor signal from the at least one pressure sensor, withat least one location of each at least one pressure sensor within theopen surgical cavity; associate at least one pressure reading,corresponding to at least one sensor signal from the at least one otherpressure sensor, with at least one location of each at least one otherpressure sensor within the open surgical cavity; and associate at leastone respective inner-cavity image with at least one location of thesubstantially rigid tool tip and at least one location of the suctiontool tip portion.
 14. The method of claim 13, further comprisingproviding the at least one camera, providing the at least one cameracomprising disposing, and laterally-orienting, the at least one cameraalong the rigid elongate tool body in one of at the substantially rigidtool tip and proximate the substantially rigid tool tip to capture atleast one lateral image from within the open surgical cavity, the atleast one lateral image externally communicable to associate at leastone respective inner-cavity image with the at least one location of thesubstantially rigid tool tip, and the at least one camera operable in anear-infrared wavelength range.
 15. The method of claim 13, furthercomprising providing the at least one pressure sensor, providing the atleast one pressure sensor comprising operatively disposing the at leastone pressure sensor along the rigid elongate tool body at a position inone of at the substantially rigid tool tip and proximate thesubstantially rigid tool tip, the pressure sensor responsive to pressurevariations applied thereto from within the open surgical cavity tooutput a sensor signal representative thereof as the substantially rigidtool tip is displaced within the open surgical cavity, the sensor signalexternally communicable to associate respective inner-cavity pressurereadings with locations of the substantially rigid tool tip.
 16. Themethod of claim 13, further comprising a set of fiducial markersexternally coupled in a fixed configuration to an externally extendingportion of the rigid elongate tool body, the markers trackable by anexternal tracking system to automatically determine the at least onelocation of the substantially rigid tool tip, with reference to the opensurgical cavity, based on a respective tracked position of the set offiducial markers.
 17. The method of claim 13, further comprising a radiofrequency transmitter to wirelessly communicate the sensor signal. 18.The method of claim 15, wherein: the pressure sensor is laterallyoriented relative to the substantially rigid tool tip, the pressuresensor comprises at least one of: a Fabry-Perot pressure sensor, apiezoresistive pressure sensor, nanotube pressure sensor, and an opticalmicroelectromechanical (MEMS) pressure sensor, the pressure sensorcomprises a plurality of pressure sensors disposed at a position in oneof: at the substantially rigid tool tip and proximate the substantiallyrigid tool tip, the pressure sensor comprises a plurality of pressuresensors collocated at a position in one of: at the substantially rigidtool tip and toward the substantially rigid tool tip, the suction tooltip portion comprises a disposable tip portion, the suction tool isdisposed at a position, in one of: at the substantially rigid tool tipand proximate the substantially rigid tool tip, to concurrently providesuction within the surgical cavity around the substantially rigid tooltip, at least one external camera is configured to align with, and view,the open surgical cavity, and the substantially rigid tool tip isoperable as a trackable pointer within the open surgical cavity the atleast one external camera and a scope is configured to align with, andview, the open surgical cavity, the at least one inner-cavity image iscomplementary to at least one external image captured by at least one ofthe at least one external camera and the scope in enhancing inner-cavityvisualization, the substantially rigid tool tip is movable within theopen surgical cavity to track at last one pressure variation resultingfrom inner-cavity bleeding in locating a bleeding site within the opensurgical cavity, the rigid elongate tool body comprises a reusable toolshaft portion and a disposable tool tip portion removably operativelyconnectable to the shaft portion, and the disposable tool tip portioncomprises the substantially rigid tool tip and the pressure sensor. 19.The method of claim 13, further comprising providing at least onecomplementary camera, providing the at least one complementary cameracomprising disposing the at least one complementary camera along therigid elongate tool body at a position, in one of at the substantiallyrigid tool tip and proximate the substantially rigid tool tip, tocapture complementary images of the open surgical cavity along acomplementary imaging axis angled toward a cavity bottom relative to atleast one camera to construct one of a 3D inner-cavity mapping and anenlarged field of view image of the open surgical cavity from the atleast one lateral image and the complementary images.
 20. A method ofimaging, locating, and mapping inner cavity characteristics within anopen surgical cavity by way of a surgical tool operable with an externaldata processing unit, the method comprising: providing the surgicaltool, providing the surgical tool comprising: providing a rigid elongatetool body comprising a substantially rigid tool tip configured to bedisplaced and tracked within the open surgical cavity for reproduciblylocating the substantially rigid tool tip within the open surgicalcavity, the rigid elongate tool body configured to operate with at leastone pressure sensor, at least one camera, and the external dataprocessing unit; and providing a suction tool comprising a suction tooltip portion, the suction tool configured to operate with at least oneother pressure sensor, at least one other camera, and the external dataprocessing unit; and considering imaging, locating, and mapping innercavity characteristics in real-time during a surgical procedure by theexternal data processing unit, considering comprising: associating atleast one pressure reading, corresponding to at least one sensor signalfrom the at least one pressure sensor, with at least one location ofeach at least one pressure sensor within the open surgical cavity;associating at least one pressure reading, corresponding to at least onesensor signal from the at least one other pressure sensor, with at leastone location of each at least one other pressure sensor within the opensurgical cavity; and associating at least one respective inner-cavityimage with at least one location of the substantially rigid tool tip andat least one location of the suction tool tip portion.